The analysis provides a critical piece of the puzzle behind more than 100 sometimes fatal infections in cardiac surgery patients since 2013, researchers said. At least five other manufacturers also sell heater-coolers in the U.S. and they all share a design that could pose a risk for infections, experts say.
This article first appeared July 12, 2017 on Kaiser Health News.
Contamination at a German factory that makes crucial machines used during open-heart surgery is the likely source of a global outbreak of deadly infections tied to the devices, the largest analysis to date shows.
Scientists using whole-genome sequencing matched the DNA fingerprints of samples taken from infected heart-surgery patients from several countries, including the U.S., to samples from the devices, called heater-cooler units, in multiple hospitals — and at the production site.
The study, published Wednesday in The Lancet Infectious Diseases journal, concludes that heater-cooler devices made at the LivaNova PLC plant in Munich, Germany, were contaminated during production.
The analysis provides a critical piece of the puzzle behind more than 100 severe — and sometimes fatal — infections in cardiac surgery patients worldwide since 2013, researchers said.
“Our study closes the missing gap,” said Stefan Niemann, a professor with the German Center for Infection Research and one of the study’s co-authors.
However, officials with LivaNova said that the study was too limited to draw conclusions.
“LivaNova is concerned that the article expresses a level of certainty about a point source tie to the manufacturing process that is not warranted by the data,” spokeswoman Deanna Wilke wrote in an email.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.